EBIXA

What it is

Ebixa contains memantine hydrochloride in film-coated tablet formulations of 10 mg and 20 mg.

Approved indications

— Treatment of the symptoms of moderately severe to severe Alzheimer's disease.

Dosing overview

The recommended maintenance dose is 20 mg per day, achieved by upward titration of 5 mg per week. Titration begins at 5 mg daily in week 1, increases to 10 mg daily in week 2, and 15 mg daily in week 3, with maintenance at 20 mg daily from week 4 onwards. For patients with mildly impaired renal function (creatinine clearance 50–80 mL/min), no dosage adjustment is required. In patients with moderate renal impairment (creatinine clearance 30–49 mL/min), the daily dose should be 10 mg, which can be increased to 20 mg per day if tolerated well after at least 7 days. In patients with severe renal impairment (creatinine clearance 5–29 mL/min), the daily dose should be 10 mg per day. In patients with mild or moderate hepatic impairment, no dosage adjustment is required.

Key safety warnings

Memantine is contraindicated in patients with epilepsy, and caution is recommended in patients with a former history of convulsions or patients with predisposing factors for epilepsy. Animal studies have reported adverse effects of memantine on the visual system, including abnormal lysosomal storage, lens opacity, corneal clouding, and lenticular changes at systemic exposures higher than anticipated clinical exposure. Specific ophthalmological examinations in a 6-month clinical study did not disclose any ocular changes during the double-blind period. At the end of a 6-month open label extension, cataract was reported in 11 out of 197 patients (6%) treated with memantine for 12 months compared to 5 out of 171 patients (3%) who received placebo in the double-blind period and then memantine for 6 months. In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III–IV), and uncontrolled hypertension were excluded, and therefore only limited data are available; patients with these conditions should be closely supervised. Factors that may raise urinary pH, including drastic changes in diet or massive ingestion of alkalising gastric buffers, require careful monitoring. Urine pH may be elevated by renal tubular acidosis or severe infections of the urinary tract with Proteus bacteria.

Contraindications

Ebixa is contraindicated in patients with hypersensitivity to either the active ingredient or any of the excipients, and in patients with a current seizure disorder or with any history of seizures.

PBS listing

No source documents contain information about PBS listing for Ebixa.

Regulatory history

Ebixa was first approved on 17 April 2003. The 20 mg film-coated tablet formulation (ARTG 156299) was first listed on 10 September 2009, and the 10 mg tablet formulation (ARTG 180400) was first listed on 15 July 2011.